Biopharma companies should recognize some of the vernacular they use for negotiating drug development and manufacturing outsourcing can set CDMOs on edge. In this editorial, we talk to biopharma veterans of outsourcing about some of the "financial frictions" brought out in new models for sponsor-provider relationships.
The convergence of data and technologies provides an opportunity for companies to make a step change in innovation and performance. Those that successfully apply the strategies to all parts of the business will thrive in an increasingly complex sector.
Biosimilars were touted as a tool for payers to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step-through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million). So what market access issues do biosimilars face in the U.S., and where could we go from here?
Part one of this series presented neuroscience-based HFE data capture methods that are beginning to penetrate HFE testing programs. This installment will discuss the challenges of utilizing advanced data capture systems in real world HFE testing programs.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.
Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).
With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.
Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
Antibodies and their derivatives are increasingly important and essential tools for biological research. Techniques to screen and characterize large numbers of antibodies and provide confident selection of the best candidates for development are therefore essential. Details described in this method will provide rapid screening in combination with data-rich selection of fragments with high affinity and the desired kinetic behavior.
To be credible, a partner needs to be able to provide technical and regulatory insight, understand your processing needs, be experienced in facility design, and provide advanced operator training.
Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
To be credible, a partner needs to be able to provide technical and regulatory insight, understand your processing needs, be experienced in facility design, and provide advanced operator training.
Despite their potential to increase the efficiency healthcare, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing.
Biomanufacturing requires large volumes of buffers, and preparation of these liquids can quickly become a bottleneck. Here, two options that can help intensify your large-scale buffer management are presented.
It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients.
